An extension trial of intrathecal therapy with monoclonal antibodies in progressive multiple sclerosis

Phase 1

• Conditions: Secondary progressive multiple sclerosis; MedDRA version: 14.1Level: PTClassification code 10063400Term: Secondary progressive multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-000721-53-SE
• Lead Sponsor: Dept of Neurology, Umeå University Hospital, Umeå, Sweden

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-16
• Last Update Posted: 24 September 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Completed the ITT-MS trial (EudraCT number 2008-002626-11)
•Other therapy not indicated, contraindicated or failed
•Judged as compliant with the protocol
•In fertile females, willing to comply with effective contraceptive methods.
•Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Eligible for any of the conventional MS therapies
•Bleeding diathesis or medication contraindicating lumbar puncture
•Cognitive defect making informed consent unreliable
•Severe, uncontrolled heart disease
•Pregnant or lactating women
•Patients having contraindication for or otherwise not compliant with MRI investigations
•Documented vulnerability to infections
•Simultaneous treatment with other immunosuppressive drugs
•Documented allergy or intolerance to Rituximab
•Severe psychiatric condition

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified